With the influx of medications to treat Hepatitis C, payers are wondering which drug offers the best value? Just recently Johnson & Johnson received FDA approval for its new hepatitis C drug Olysio combined with Sovaldi in a two drug regimen treatment. Sovaldi is made and manufactured by Gilead Science. Gilead Science just recently gained FDA approval for its new hepatitis combination drug Harvoni, which is Sovaldi plus Ledipasvir. All three regimens have shown sustained virologic response (cure rate) of 90% or more in clinical trials.
The FDA uses well designed clinical trials to evaluate the efficacy and safety of drugs in the US before they are marketed. Clinical trial design often consist of two-arm trials comparing drug versus placebo (an inactive agent). For hepatitis C, the majority of clinical trials compared older less effective treatments with the new drugs seeking approval. The FDA approved Sovaldi based on data from four phase III clinical studies (NEUTRINO, FISSION, POSITRON and FUSION). Cure rates ranged from 80 to 90% in patients infected with specific hepatitis C genotype 1. In clinical trials (ION-1, ION-2 and ION-3) Harvoni showed a 99% cure rate in patients infected with genotypes 1, which is impressive. In clinical trials (COSMOS) 12 week-treatment, Olysio plus Sovaldi showed cure rates of 90 to 95% for patients with hepatitis C genotype 1.
All these drugs show comparable results and effectiveness in clinical studies. However, they all have at a hefty price tag. A 12-week treatment for Sovaldi is $84,000, a 12-week treatment for Harvoni is $94,500, and a 12-week treatment of Olysio is $66,000. Combining Olysio and Sovaldi would cost $150,000, the sum of the cost of the individual drugs. Payers have been vocal about their discontent about the prices of these new hepatitis C treatments.
Would direct comparison of these agents in head-to-head clinical trials help validate the price tags of these drugs and clarify which agent is best? A head-to-head clinical trial would show once and for all which drug is truly superior and may be used to justify the hefty price of the drug. A head-to-head clinical trial will clarify for insurance companies which agents to include in their formulary while patients and doctors will have more data to select the optimal treatment. Patients will know that they are receiving the best treatment option available based on these clinical trials. Lastly, head-to-head trials could benefit pharmaceutical companies by proving that they have a superior drug on the market.
Drugs in a saturated therapeutic class compete for market share; differentiation based on head-to-head trials could prove very beneficial. Many prescribers use data collected from clinical trials to guide prescribing. There are few head-to-head clinical trials for various reasons. New hepatitis treatments provide an opportunity for head-to-head clinical trials. Comparing Olysio plus Solvadi versus Harvoni would be interesting. Looking toward the future there are new hepatitis C treatments awaiting FDA approval. Bristol-Myers Squibb filed for approval of daclatasvir and asunaprevir; AbbVie filed for approval for a multi-drug regimen that consists of the fixed-dose combination of the protease inhibitor ABT-450 and ritonavir co-formulated with the NS5A inhibitor ombitasvir (ABT-267), as well the non-nucleoside polymerase inhibitor dasabuvir (ABT-333). Comparing these new regimens with the recently approved drugs would be a valuable head-to-head match up. In the next year there will be more than 5 treatments on the market and knowing which one is superior will be beneficial to delivering the best patient outcome.